SURGIFLO® by Ferrosan™ is a pre-filled surgical hemostatic applicator that includes a pre-filled, flowable hemostat in a syringe that offers the option to customize the consistency by controlling the amount of saline or thrombin used. The flowable hemostat is a haemostatic Matrix, which is a sterile, absorbable porcine gelatin or other anti-bleeding agent. An applicator tip is secured to the syringe via a Luer-lock. The flowable haemostatic agent product is applied to a target area by positioning the free end of the applicator tip near a target site and then expelling an amount of the flowable haemostat. The surgical or haemostatic applicator is supplied with two applicator tips for precise placement of the flowable. This gives surgeons an option of choosing between a flexible and malleable applicator tip that has “memory” to ensure it stays at the optimum angle for easier access and exact product placement, and a non-malleable tip that can be cut with nursing dressing scissors to a desired length for providing the required penetration depth.
The SURGIFLO® surgical or haemostatic applicator is particularly useful in connection with minimally invasive surgical techniques wherein a plurality of devices may be introduced into the body through small incisions. One example of a common minimally invasive surgery involves laparoscopic surgical procedures. Laparoscopic procedures may be used to treat hernias, colon dysfunctions, gastroesophageal reflux disease, and gallbladder disorders. These procedures are considered minimally invasive, and typically a patient undergoing one of the procedures returns home hours after undergoing surgery.
Generally, laparoscopic procedures require making at least one small incision in the patient's body near the area of interest. A cannula or trocar may be inserted into the incision for convenient instrument access. Thereafter, various surgical instruments are introduced into the patient's body through the incision(s). Generally, these instruments enable the surgeon to visualize the inside of the patient's body and access the internal organs of the patient. Current laparoscopic surgical instruments include cameras, scissors, dissectors, graspers and retractors. One of the difficulties presented when performing minimally invasive surgical procedures relates to applying a hemostat to a target area. Applying the hemostat to the bleeding site may be difficult as the site may be some distance within the body and access is limited. Moreover other parts of the body may impede the manipulation of an elongated catheter to reach these relatively remote sites. This problem can be reduced by using the known formable or malleable tip.
The known malleable tip retains the desired configuration until it is reshaped into a different configuration and it is shaped or formed, typically by manual bending, into a desired configuration.
The known malleable/formable tip includes a tube with a large lumen configured to receive the flowable from the syringe. A malleable insert in the form of a steel wire is positioned within a second smaller lumen of the malleable tip. The malleable insert assists in retaining the formable tip in the desired configuration.
The ability to shape the formable section increases the ability to accurately position the applicator device, while minimizing the user's manipulation of the device.